Experts Emphasize the Importance of Adhering to Good Clinical Practices for Ensuring Patient Safety and Accuracy of Data during Clinical Trials

• The Good Clinical Practice workshop being supported by Roche Pharmaceuticals saw participation of over 50 experts from the UAE Ministry of Health, Dubai Health Authority, Health Authority of Abu Dhabi hospitals, Sultan Qaboos University Hospital in Oman and Hamad Medical Corporation Hospital in Qatar.
• Ministry of Health in UAE, Dubai Health Authority and Health Authority of Abu Dhabi follow strict ethical guidelines to ensure adoption of safe and effective clinical trial procedures. The workshop educated the participants on the latest introductions in the guidelines and measures.

Dubai, United Arab Emirates, December 20, 2015:  With the rising incidences of communicable and non-communicable diseases, furthering clinical research is the need of the hour. Patient safety during clinical trials and credibility of data is a key concern for regulators and researchers. Recognizing this challenge and as part of its ongoing efforts to advance medical research in the region, Roche Pharmaceuticals held a Good Clinical Practice workshop on 18-19 December 2015 in UAE.  This year, a key focus of the initiative was on training and developing the skills of potential investigators and researchers in the UAE and the Gulf.  

During the workshop, researchers received an overview of ethical and regulatory guidelines, with in-depth discussions on patient safety by adhering to protocols, documenting data, undertaking risk based monitoring and setting up systematic processes required to safeguard the interest of patients. 

In addition there was a separate session for the Ethics Committee members and Health Authority members responsible for reviewing study documents and providing approval to conduct clinical trials in UAE and the Gulf. They discussed the GCP requirements with regards to Ethics in Clinical Trials, Ethics Scope and Responsibility, Quality in Clinical Research and Challenges in Clinical Trials in the region. 

“The UAE believes that “Research today saves lives tomorrow.” Thus, we are pleased to join the international research community by participating in global multicenter clinical trials. The Ministry of Health and all medical organizations under its jurisdiction are committed to ensuring that research is conducted according to international regulatory and ethical standards, including Good Clinical Practice, to protect patient safety and the ensure accuracy of research data. We support researchers, and healthcare professionals by educating them about GCP and by helping them implement GCP in their research activities.” says Dr. Ghada Al Tajir, Director of the Clinical Research Centre at Al Qassimi Hospital, UAE.

Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of research subjects are protected and respected. 

Before medical products can be introduced onto the market or into public health programs, they must undergo a series of investigations designed to evaluate safety and efficacy within the parameters of toxicity, potency, dose finding, and field conditions. Full information must be documented on therapeutic indications, method of administration and dosage, contraindications, warnings, safety measures, precautions, interactions, effects in target populations and safety information. 

“Innovation through research is an integral component of SEHA vision. Iterative innovative science need to be fast forwarded in the UAE to shape the future of human health and achieve outstanding health outcomes, especially in the areas of life style diseases such as diabetes, cardiovascular and, cancer. In order to achieve research driven quality patient care, the value of clinical trials has to be communicated to the patients, their families, and the community. Given the importance and complexity of the conduct of clinical trials, it is relevant to train physicians, regulators, ethics committee members, support staff and policy makers. Effectively trained research professionals adopt high standards for patient safety and patient management in clinical trials. Recent initiatives by the government to train medical residents for research is a great step in that direction. Good Clinical Practice, a global standard, workshops are helpful in giving the researchers a composite platform for knowledge, skill and aptitude development to undertake research projects towards ensuring productive clinical outcomes.” said Dr. Satish Chandra Nair, Associate Professor UAEU, Director of Medical Research Tawam Hospital and the Vice Chairman of the Al Ain Medical District Human Research Ethics Committee, Abu Dhabi Eastern Region.

 “Through this initiative our endeavor is to advance and support scientific thinking to drive the best results for maximum patient benefit. At Roche we believe that clinical trials are essential to providing the scientific data to determine whether new drugs, diagnostics or procedures are both safe and effective when used to diagnose and treat people. We collaborate with regulatory agencies, monitor reports for our patients and communicate on our product safety activities in keeping with international standards. The well-being of our patients is at the forefront of all that we do. To ensure that every Roche product is both effective and safe, we have established a systematic process designed to optimize patient safety throughout the lifecycle of a medicine,” says Slobodan Nedeljković, Head of Medical, Roche Middle East Sub-regions.

Since 2011, Roche UAE and Gulf has participated in 10 multi-centers global and regional studies in different disease areas such as Hepatitis C (HCV), Rheumatoid Arthritis and Oncology (breast and lung cancer). Medical research or clinical trials are essential to providing the scientific evidence or data that is required to determine whether new drugs, diagnostics or new procedures are both safe and effective when used to diagnose and treat patients. The company’s operation in the GCC has been instrumental in putting the region in the global scenario of clinical research and innovation.